Agence du Médicament de Madagascar
AGMED · Madagascar · africa
Madagascar's Agence du Médicament — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general national pharmaceutical and medical device framework as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- africa
- Country
- Madagascar
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
- Website
- https://www.sante.gov.mg
Relevant Regulation Codes
- Malagasy Code de la Santé — pharmaceutical and device provisions
- Malagasy national medical device regulatory framework
Prescriber Requirements
- Ordre des Médecins de Madagascar–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
AGMED registration as applicable; French and Malagasy-language labelling. Standard cold-chain conditions, with logistical constraints typical for island distribution.
Import/Export Rules
AGMED and Ministry of Public Health import authorisation; veterinary services clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Not covered under public insurance schemes for leech therapy specifically.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; falls under general medical device / traditional medicine framework as appropriate. Madagascar has rich traditional medicine practice; whether hirudotherapy is recognised under any statutory framework has not been independently mapped by ASH.
Related Jurisdictions
ANSM — France
Home regulator of Ricarimpex SAS — the world's only leech manufacturer simultaneously CE-marked and FDA-cleared, operating under ANSM oversight since 1845.
SAHPRA — South Africa
South Africa's SAHPRA (created 2018, replacing the Medicines Control Council) — leech therapy regulated as a medical device under the Medicines and Related Substances Act; traditional-health practitioners under separate THP Council.
NAFDAC — Nigeria
Nigeria's national agency for food and drug administration and control — leech-specific regulatory pathway has not been independently verified by ASH.
DMP Morocco — Morocco
Morocco's Directorate of Medicines and Pharmacy under the Ministry of Health — leech-specific regulatory pathway has not been independently verified by ASH.